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Understanding the 503B Bulks List Under Section 503B of the Federal Food, Drug, and Cosmetic Act, outsourcing facilities are permitted to compound drugs using bulk substances only under specific conditions

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10.1002/smll.201905233 Small 111 RimassaL.AssenatE.Peck-RadosavljevicM.PrachtM.ZagonelV.MathurinP.et al (2018)

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